In sub-Saharan Africa, health-care provision for chronic conditions is fragmented. The aim of this study was to determine whether integrated management of HIV, diabetes, and hypertension led to improved rates of retention in care for people with diabetes or hypertension without adversely affecting rates of HIV viral suppression among people with HIV when compared to standard vertical care in medium and large health facilities in Uganda and Tanzania. In INTE-AFRICA, a pragmatic cluster-randomised, controlled trial, we randomly allocated primary health-care facilities in Uganda and Tanzania to provide either integrated care or standard care for HIV, diabetes, and hypertension. Random allocation (1:1) was stratified by location, infrastructure level, and by country, with a permuted block randomisation method. In the integrated care group, participants with HIV, diabetes, or hypertension were managed by the same health-care workers, used the same pharmacy, had similarly designed medical records, shared the same registration and waiting areas, and had an integrated laboratory service. In the standard care group, these services were delivered vertically for each condition. Patients were eligible to join the trial if they were living with confirmed HIV, diabetes, or hypertension, were aged 18 years or older, were living within the catchment population area of the health facility, and were likely to remain in the catchment population for 6 months. The coprimary outcomes, retention in care (attending a clinic within the last 6 months of study follow-up) for participants with either diabetes or hypertension (tested for superiority) and plasma viral load suppression for those with HIV (>1000 copies per mL; tested for non-inferiority, 10% margin), were analysed using generalised estimating equations in the intention-to-treat population. This trial is registered with ISCRTN 43896688. Between June 30, 2020, and April 1, 2021 we randomly allocated 32 health facilities (17 in Uganda and 15 in Tanzania) with 7028 eligible participants to the integrated care or the standard care groups. Among participants with diabetes, hypertension, or both, 2298 (75·8%) of 3032 were female and 734 (24·2%) of 3032 were male. Of participants with HIV alone, 2365 (70·3%) of 3365 were female and 1000 (29·7%) of 3365 were male. Follow-up lasted for 12 months. Among participants with diabetes, hypertension, or both, the proportion alive and retained in care at study end was 1254 (89·0%) of 1409 in integrated care and 1457 (89·8%) of 1623 in standard care. The risk differences were –0·65% (95% CI –5·76 to 4·46; p=0·80) unadjusted and –0·60% (–5·46 to 4·26; p=0·81) adjusted. Among participants with HIV, the proportion who had a plasma viral load of less than 1000 copies per mL was 1412 (97·0%) of 1456 in integrated care and 1451 (97·3%) of 1491 in standard care. The differences were –0·37% (one-sided 95% CI –1·99 to 1·26; p<0·0001 unadjusted) and –0·36% (–1·99 to 1·28; p<0·0001 adjusted). In sub-Saharan Africa, integrated chronic care services could achieve a high standard of care for people with diabetes or hypertension without adversely affecting outcomes for people with HIV. European Union Horizon 2020 and Global Alliance for Chronic Diseases.

中文翻译：

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撒哈拉以南非洲地区艾滋病毒、糖尿病和高血压的综合管理（INTE-AFRICA）：一项实用的整群随机对照试验

在撒哈拉以南非洲地区，针对慢性病的医疗保健服务十分分散。本研究的目的是确定与标准垂直护理相比，艾滋病毒、糖尿病和高血压的综合管理是否可以提高糖尿病或高血压患者的护理保留率，而不会对艾滋病毒感染者的艾滋病病毒抑制率产生不利影响乌干达和坦桑尼亚的大中型医疗机构。在 INTE-AFRICA 一项务实的整群随机对照试验中，我们随机分配了乌干达和坦桑尼亚的初级卫生保健设施，为艾滋病毒、糖尿病和高血压提供综合护理或标准护理。随机分配 (1:1) 按位置、基础设施水平和国家进行分层，采用置换区组随机化方法。在综合护理组中，患有艾滋病毒、糖尿病或高血压的参与者由相同的医护人员管理，使用相同的药房，具有相似设计的医疗记录，共享相同的挂号和等候区，并拥有综合实验室服务。在标准护理组中，这些服务针对每种情况垂直提供。如果患者确诊患有艾滋病毒、糖尿病或高血压，年龄在 18 岁或以上，居住在医疗机构的服务对象范围内，并且可能在服务对象范围内停留 6 年，则患者有资格参加试验。几个月。共同主要结果，患有糖尿病或高血压的参与者的护理保留率（在研究随访的最后 6 个月内到诊所就诊）（经优越性测试）以及 HIV 感染者的血浆病毒载量抑制（> 1000 拷贝/毫升；测试非劣效性（10% 裕度），并在意向治疗人群中使用广义估计方程进行分析。该试验在 ISCRTN 43896688 上注册。2020 年 6 月 30 日至 2021 年 4 月 1 日期间，我们将 32 个医疗机构（17 个在乌干达，15 个在坦桑尼亚）和 7028 名符合条件的参与者随机分配到综合护理组或标准护理组。在患有糖尿病、高血压或两者兼而有之的参与者中，3032 名参与者中有 2298 名 (75·8%) 为女性，3032 名参与者中有 734 名 (24·2%) 为男性。在仅感染艾滋病毒的参与者中，3365 名参与者中有 2365 名 (70·3%) 为女性，3365 名参与者中有 1000 名 (29·7%) 为男性。随访持续12个月。在患有糖尿病、高血压或两者兼有的参与者中，研究结束时存活并继续接受护理的比例为 1409 名接受综合护理的患者中的 1254 名 (89·0%) 和 1457 名接受标准护理的 1623 名患者 (89·8%)。未经调整的风险差异为 –0·65%（95% CI –5·76 至 4·46；p=0·80），以及 –0·60%（–5·46 至 4·26；p=0·81） ）调整。在艾滋病毒感染者中，综合护理中血浆病毒载量低于 1000 拷贝/毫升的比例为 1456 人中的 1412 人 (97·0%)，标准护理中的 1491 人中为 1451 人 (97·3%)。差异为 –0·37%（单侧 95% CI –1·99 至 1·26；p<0·0001 未调整）和 –0·36%（–1·99 至 1·28；p<0 ·0001调整）。在撒哈拉以南非洲地区，综合慢性病护理服务可以为糖尿病或高血压患者提供高标准的护理，而不会对艾滋病毒感染者的治疗结果产生不利影响。欧盟地平线 2020 和全球慢​​性病联盟。